Checklist of Information for Inclusion in Reports of Clinical Trials

In December 1994, Annals of Internal Medicine published a paper titled “Call for Comments on a Proposal to Improve Reporting of Clinical Trials in the Biomedical Literature” [1]. The proposal was the undertaking of the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, which includes the principal editors of four medical journals, four biostatisticians, two biomedical investigators, three academic biomedical editors, and an information scientist, all of whom participate professionally in the planning, performance, reporting, or publishing of clinical trials. This call for comments also appeared in the journals of several professional societies for scientific editors, including the American Medical Writers Association, the Council of Biology Editors, the European Association of Science Editors, and the International Federation of Science Editors. In this call for comments, the Asilomar Working Group stated the following.

1. Neither investigators reporting clinical trials nor journal editors selecting reports of trials for publication consistently follow the excellent guidelines published in the biomedical literature.

2. The reporting of data from clinical trials might be more consistent and complete if there were a readily accessible and more concise guide to the most basic methodologic elements required in reports of clinical trials—a checklist.

3. Because the editors of journals publishing reports of clinical trials are the persons best positioned to promote better reporting by the investigators submitting papers to their journals, such a checklist could help journal editors and peer reviewers evaluate the reports of trials submitted for publication.

In response to the call for comments, the Working Group received more than 150 letters from editors, clinicians, clinical investigators, statisticians, and others worldwide, and these letters …